MORF-057 is a selective, oral small molecule inhibitor of the α4β7 integrin in development to treat patients suffering from inflammatory bowel disease (IBD) that is currently in phase 2b studies.
Morphic’s Phase 2 EMERALD program evaluates MORF-057 in patients with moderate-to-severe ulcerative colitis (UC)
The EMERALD-1 Phase 2a study achieved its primary endpoint, demonstrated consistent, clinically meaningful improvements across secondary and exploratory measures, and was well tolerated with no safety signal observed
In the EMERALD-1 open label Phase 2a study, MORF-057 demonstrated a statistically significant reduction of 6.4 points (p=0.002) from baseline at week 12 in the Robarts Histopathology Index (RHI) score and achieved 26% clinical remission as measured by Modified Mayo Clinic Score (mMCS).
The EMERALD-2 global Phase 2b randomized, double-blind, placebo-controlled trial of MORF-057 in patients with moderate-to-severe UC initiated in November 2022 and is enrolling as projected. Results are expected in the first half of 2025.
Phase 1 clinical studies of MORF-057 demonstrated a favorable safety and pharmacokinetic profile
In Phase 1 studies, α4β7 receptor occupancy greater than 99% was observed in multiple dose cohorts, exceeding pre-specified targets. Further, a series of preclinical results strongly support MORF-057 as a potential oral approach to α4β7 inhibition with results demonstrating similar activity and mechanistic patterns to vedolizumab.
For more information on the EMERALD clinical trials please click here.